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Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in thienopyridine users remains unclear.
The aims of the randomized double-blind comparison study are to compare the efficacy of Proton Pump Inhibitor and H2 receptor antagonist for the prevention of recurrent peptic ulcers in thienopyridine users. We plan to enroll 334 thienopyridine (clopidogrel or ticlopidine) users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) pantoprazole (40 mg qd) or (2) famotidine (40 mg qd) for 6 months.The ulcer recurrence rate between the treatment groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| proton pump inhibitor group | Active Comparator | Pantoprazole Tab 40mg qd for 6 monthrs. |
|
| histamine-2 receptor antagonist group | Experimental | famotidine Tab 40 mg qd for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| histamine-2 receptor antagonist group | Drug | famotidine tab 40 mg qd for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ulcer Recurrence | Follow-up endoscopy was performed at the end of the 6th month | six month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ping-I Hus, Bachelor | Kaohsiung Veterans General Hospital. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16793712 | Background | Savi P, Nurden P, Nurden AT, Levy-Toledano S, Herbert JM. Clopidogrel: a review of its mechanism of action. Platelets. 1998;9(3-4):251-5. doi: 10.1080/09537109876799. | |
| 15816504 | Background | Boeynaems JM, van Giezen H, Savi P, Herbert JM. P2Y receptor antagonists in thrombosis. Curr Opin Investig Drugs. 2005 Mar;6(3):275-82. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Pump Inhibitor Group | Pantoprazole Tab 40mg qd for 6 monthrs. proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months. |
| FG001 | Histamine-2 Receptor Antagonist Group | famotidine Tab 40 mg qd for 6 months. histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Pump Inhibitor Group | Pantoprazole Tab 40mg qd for 6 monthrs. proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months. |
| BG001 | Histamine-2 Receptor Antagonist Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Ulcer Recurrence | Follow-up endoscopy was performed at the end of the 6th month | Intention to treat | Posted | Number | participants | six month |
|
six month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proton Pump Inhibitor Group | Pantoprazole Tab 40mg qd for 6 monthrs. proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Systematic Assessment | abdominal pain sufficient to interfere with daily life |
The trial was performed in a single country
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ping-I Hsu | Kaohsiung Veterans General Hospital | +886-7-3422121 | 8233 | pihsu@vghks.gov.tw |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2018 | Jun 24, 2019 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015738 | Famotidine |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| proton pump inhibitor group | Drug | pantoprazole tab 40 mg qd for 6 months. |
|
|
| 11519503 | Background | Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746. |
| 16531616 | Background | Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12. |
| 11520521 | Background | Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. doi: 10.1016/s0140-6736(01)05701-4. |
| 8918275 | Background | CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996 Nov 16;348(9038):1329-39. doi: 10.1016/s0140-6736(96)09457-3. |
| 10868447 | Background | Fork FT, Lafolie P, Toth E, Lindgarde F. Gastroduodenal tolerance of 75 mg clopidogrel versus 325 mg aspirin in healthy volunteers. A gastroscopic study. Scand J Gastroenterol. 2000 May;35(5):464-9. doi: 10.1080/003655200750023705. |
| 21144850 | Background | Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011 Mar;140(3):791-8. doi: 10.1053/j.gastro.2010.11.056. Epub 2010 Dec 7. |
| 15659723 | Background | Chan FK, Ching JY, Hung LC, Wong VW, Leung VK, Kung NN, Hui AJ, Wu JC, Leung WK, Lee VW, Lee KK, Lee YT, Lau JY, To KF, Chan HL, Chung SC, Sung JJ. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med. 2005 Jan 20;352(3):238-44. doi: 10.1056/NEJMoa042087. |
| 11353854 | Background | Ma L, Elliott SN, Cirino G, Buret A, Ignarro LJ, Wallace JL. Platelets modulate gastric ulcer healing: role of endostatin and vascular endothelial growth factor release. Proc Natl Acad Sci U S A. 2001 May 22;98(11):6470-5. doi: 10.1073/pnas.111150798. Epub 2001 May 15. |
| 15300570 | Background | Laine L, Maller ES, Yu C, Quan H, Simon T. Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: a double-blind trial. Gastroenterology. 2004 Aug;127(2):395-402. doi: 10.1053/j.gastro.2004.05.001. |
| 19837071 | Background | Ng FH, Wong SY, Lam KF, Chu WM, Chan P, Ling YH, Kng C, Yuen WC, Lau YK, Kwan A, Wong BC. Famotidine is inferior to pantoprazole in preventing recurrence of aspirin-related peptic ulcers or erosions. Gastroenterology. 2010 Jan;138(1):82-8. doi: 10.1053/j.gastro.2009.09.063. Epub 2009 Nov 11. |
| 17338735 | Background | Lanas A, Garcia-Rodriguez LA, Arroyo MT, Bujanda L, Gomollon F, Forne M, Aleman S, Nicolas D, Feu F, Gonzalez-Perez A, Borda A, Castro M, Poveda MJ, Arenas J; Investigators of the Asociacion Espanola de Gastroenterologia (AEG). Effect of antisecretory drugs and nitrates on the risk of ulcer bleeding associated with nonsteroidal anti-inflammatory drugs, antiplatelet agents, and anticoagulants. Am J Gastroenterol. 2007 Mar;102(3):507-15. doi: 10.1111/j.1572-0241.2006.01062.x. |
| 12940930 | Background | Ng FH, Wong SY, Chang CM, Chen WH, Kng C, Lanas AI, Wong BC. High incidence of clopidogrel-associated gastrointestinal bleeding in patients with previous peptic ulcer disease. Aliment Pharmacol Ther. 2003 Aug 15;18(4):443-9. doi: 10.1046/j.1365-2036.2003.01693.x. |
| 19904241 | Background | Laine L, Hennekens C. Proton pump inhibitor and clopidogrel interaction: fact or fiction? Am J Gastroenterol. 2010 Jan;105(1):34-41. doi: 10.1038/ajg.2009.638. Epub 2009 Nov 10. |
| 19726077 | Background | Sibbing D, Kastrati A. Risk of combining PPIs with thienopyridines: fact or fiction? Lancet. 2009 Sep 19;374(9694):952-954. doi: 10.1016/S0140-6736(09)61562-2. Epub 2009 Aug 31. No abstract available. |
| 19470853 | Background | Norgard NB, Mathews KD, Wall GC. Drug-drug interaction between clopidogrel and the proton pump inhibitors. Ann Pharmacother. 2009 Jul;43(7):1266-74. doi: 10.1345/aph.1M051. Epub 2009 May 26. |
| 19106083 | Background | Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22. |
| 19258584 | Background | Ho PM, Maddox TM, Wang L, Fihn SD, Jesse RL, Peterson ED, Rumsfeld JS. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009 Mar 4;301(9):937-44. doi: 10.1001/jama.2009.261. |
| 19176635 | Background | Juurlink DN, Gomes T, Ko DT, Szmitko PE, Austin PC, Tu JV, Henry DA, Kopp A, Mamdani MM. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009 Mar 31;180(7):713-8. doi: 10.1503/cmaj.082001. Epub 2009 Jan 28. |
| 20925534 | Background | Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Scirica BM, Murphy SA, Cannon CP; COGENT Investigators. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010 Nov 11;363(20):1909-17. doi: 10.1056/NEJMoa1007964. Epub 2010 Oct 6. |
famotidine Tab 40 mg qd for 6 months.
histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| history of smoking | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
| EG001 | Histamine-2 Receptor Antagonist Group | famotidine Tab 40 mg qd for 6 months. histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months. | 0 | 51 | 0 | 51 | 1 | 51 |
|
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| D013272 | Stomach Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |